Clofarabine Used with DaunoXome in Childhood AML - CLOUD Trial

• Research type

  Research Study

• Full title

  Phase I Dose Escalation Study of Clofarabine and Liposomal Daunorubicin in Childhood and Adolescent AML

• IRAS ID

  3909

• Contact name

  Pamela/P Kearns

• Eudract number

  2008-002288-14

• ISRCTN Number

  N/A

• Research summary

  Approximately 35% of children and adolescents with acute myeloid leukaemia are not cured with current therapies. New drugs or drug combinations need to be developed to improve survival for this patient group. The next front line treatment for AML will evaluate the potential benefit of the combination of the new drug clofarabine with dauorubicin in a sub-group of patients known to highest risk of treatment failure. This combination has been tested on elderly patients and the safe dose to combine these drugs in adults is known, however this information is not known for children. These drugs are both used separately in the treatment of children with leukaemia but have not been given in combination with each other. The recommended dose of clofarabine in children when used alone is 52mg/m2/day compared to 30-40mg/m2/day in adults and the elderly. It is therefore important to evaluate the correct dose of the combination in children to ensure that children receive both a safe and effective combination. This trial aims to establish the safe and tolerable dose of clofarabine when combined with a fixed dose of liposomal daunorubicin. The efficacy of this combination in children will be subsequently evaluated front line therapy protocols for high risk sub-groups of AML and relapsed AML, for which the current therapies are inadequate.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/36

• Date of REC Opinion

  28 Oct 2008

• REC opinion

  Further Information Favourable Opinion